Ra Process
5 months ago
Johnson & Johnson is recruiting for a RA Process & Compliance Officer NEMA, to belocated in Cairo, Egypt.
**Key Responsibilities**:
**Manage the Regulatory Affairs **Process **& **Compliance activities**:
- Keep oversight, reporting and support for Labeling management and systems.
- Assess and manage development of new business support processes and capabilities to meet the needs of the evolving Business and Regulatory environment.
- Design, implement and assess, as needed, systems and tools to support the MA-FSA Regulatory team’s activity.
- Identify, set and monitor individual objectives and the means of implementation.
- Radiate positive compliance driven environment and business continuity.
- Organize and facilitate collaboration
**Manage Quality and Operational **processes linked to RA **activities**:
- Develop, deploy and optimize processes vertically between Global/EMEA, Regional office and countries and horizontally to ensure alignment within NEMA cluster (e.g. work closely with Near East Compliance professional)
- Ensure efficient implementation and maintenance of the key RA processes and corresponding systems, including but not limited to: Change controls, local deviations, CAPAs and escalations; Document management, knowledge management, records management and archiving; onboarding process and training ; Regulatory Intelligence
- Provide regulatory process support for Regulatory Experts and professionals to ensure they recognize procedures they should adhere to.
**Support RA compliance in the region**:
- Establish and maintain Compliance oversight in the region through appropriate tools (e.g. dashboards and trend analyses of compliance data from GRA systems)
- Produce Monthly Metrics on labelling, CMC variations and renewals being processed. Identify any backlog variations or renewals and work with RA to ensure appropriate actions are being taken to manage the backlog including opening of Quality Issues where necessary.
- Subject Matter Expert for implementation and compliance of GRA Systems
- Coordinate the RA preparation, input, support and follow-up of inspections, audits and compliance related processes.
- Main interface/contact point for all Systems and RIM discussions involving or impacting the region
- Guide RA Experts and Professionals on maintaining compliance for internal systems.
**Qualifications**:
**Qualifications**:
**Experience and Skills**:
- Minimally degree in Pharmacy.
- 4 years’ experience in Regulatory Affairs within a multinational organization, preferably regulatory compliance experience
- Having a professional working proficiency in French is a plus
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
- Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
- Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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